Sixth Generation High-sensitivity Cardiac Troponin T for the Early Rule Out of Myocardial Infarction: a Controlled Before and After Study (STEREO-MI)

Cardiac troponin is a protein released into the blood when the heart muscle is damaged. Measuring this protein helps doctors diagnose a heart attack (also called a myocardial infarction). Modern blood tests, known as high-sensitivity cardiac troponin assays, can detect very small amounts of this protein.

A new version of this test, called Troponin T high-sensitivity Gen 6, has recently been developed and approved for use. It is designed to be more accurate and reliable, detecting smaller changes in troponin levels and being less affected by technical interference. The investigators believe this improved test will allow doctors to diagnose heart attacks more quickly and decide sooner who needs to stay in hospital and who can safely go home. This could help reduce overcrowding in Accident and Emergency (A&E) departments, a major challenge for the NHS.

This study will examine whether switching to this new test across a health board shortens the time patients with suspected heart attacks spend in the Emergency Department. The investigators will use information from the DataLoch Heart Disease Registry, which automatically collects anonymised hospital data for patients attending with possible heart attacks. The investigators will compare data from one year before and one year after implementation to see whether average length of stay changes and to confirm that patient safety remains high. This investigators will also measure both the current and new versions of the troponin test in surplus blood samples collected during two six-month periods-one before and one after the new test is introduced. This will allows the investigators to directly compare the two tests reliably.

Patients will not need to do anything extra to take part - the study uses information and samples already collected as part of their usual care.

Study Overview

• Status: Not yet recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Diagnostic test: fifth-generation high sensitivity cardiac troponin T assay; Diagnostic test: sixth-generation high sensitivity cardiac troponin T assay

• Study Type: Interventional
• Enrollment (Estimated): 19500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew R Chapman, MD PhD; Phone Number: +44131 242 6200; Email: a.r.chapman@ed.ac.uk

Study Locations

• United Kingdom
  • Midlothian
    • Edinburgh, Midlothian, United Kingdom, EH4 2XU
      • Western General Hospital
      • Contact: Andrew R Chapman, MD PhD; Phone Number: +44131 242 6200; Email: a.r.chapman@ed.ac.uk
      • Principal Investigator: Andrew R Chapman, MD PhD
    • Edinburgh, Midlothian, United Kingdom, EH16 4SA
      • The Royal Infirmary of Edinburgh
      • Contact: Andrew R Chapman, MD PhD; Phone Number: +44131 242 6200; Email: a.r.chapman@ed.ac.uk
      • Principal Investigator: Andrew R Chapman, MD PhD
  • West Lothian
    • Livingston, West Lothian, United Kingdom, EH54 6PP
      • St. John's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years and over.
• Attending clinician suspects acute coronary syndrome.
• At least one measurement of cardiac troponin using the Gen 5 or Gen 6 hs-cTnT assay.

Exclusion Criteria:

• Insufficient clinical information to perform record linkage.
• Not resident in Scotland.
• Previous enrolment in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pre-implementation; Consecutive patients presenting with suspected acute coronary syndrome for 12 months prior to the implementation of the sixth generation hs-cTnT assay will be enrolled into the "pre-implementation" arm, where care is guided by the current, fifth-generation assay	Diagnostic test: fifth-generation high sensitivity cardiac troponin T assay; Elecsys Troponin T Gen 5 is an immunoassay for the in vitro quantitative determination of cardiac troponin T in human serum and plasma, that can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g. acute myocardial infarction (AMI). It is the most widely used high-sensitivity troponin assay globally.; Other Names: Troponin T gen 5
Experimental: Post-implementation; Consecutive patients presenting with suspected acute coronary syndrome for 12 months after the implementation of the sixth generation hs-cTnT assay will be enrolled into the "post-implementation" arm, where care is guided by the sixth-generation assay	Diagnostic test: sixth-generation high sensitivity cardiac troponin T assay; Elecsys Troponin T hs Gen 6 is an immunoassay for the in vitro quantitative determination of cardiac troponin T in human serum and plasma, that can be used as an aid in the differential diagnosis of acute coronary syndrome to identify necrosis, e.g. acute myocardial infarction (AMI). In contrast to the previous generation of the assay (Elecsys Troponin T hs), the Gen 6 assay has been standardised against recombinant human cardiac troponin T, and has been demonstrated to have greater analytical precision and resistance to interference.; Other Names: Troponin T high sensitivity generation six; TnT hs Gen 6

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay within the Emergency Department	Length of stay within the Emergency Department, defined as the time from arrival until discharge from the Emergency Department or referral for admission to hospital.	From Emergency Department arrival until Emergency Department discharge or hospital admission, up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Total length of hospital stay from presentation until discharge from hospital	From initial presentation until hospital discharge, up to 1 year
Hospital admission	Admission to hospital during index presentation	From initial presentation to the Emergency Department up to 7 days
Serial cardiac troponin measurements	Number of serial cardiac troponin measurements during index admission	From initial presentation until hospital discharge, up to 1 year
Cardiovascular death at 30 days	Cardiovascular death at 30 days following presentation defined according to the Standardized Data Collection for Cardiovascular Trials Initiative: deaths that result from an AMI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to CV procedures, death due to CV hemorrhage, and death due to other CV causes (ICD10 codes I00-I99, limited to positions 1 or 2 in the record of death)	From initial presentation until 30 days after initial presentation
Cardiovascular death at 1 year	Cardiovascular death at 30 days following presentation defined according to the Standardized Data Collection for Cardiovascular Trials Initiative: deaths that result from an AMI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to CV procedures, death due to CV hemorrhage, and death due to other CV causes (ICD10 codes I00-I99, limited to positions 1 or 2 in the record of death)	From initial presentation until 1 year after initial presentation
Myocardial infarction after discharge at 30 days	Myocardial infarction following discharge from hospital at 30 days (a hospital episode recorded in the Scottish Morbidity Record associated with ICD10 codes I21 or I22, limited to position 1 or 2 on the discharge list)	From initial hospital discharge until 30 days following index presentation
Myocardial infarction after discharge at 1 year	Myocardial infarction following discharge from hospital at 30 days (a hospital episode recorded in the Scottish Morbidity Record associated with ICD10 codes I21 or I22, limited to position 1 or 2 on the discharge list)	From initial hospital discharge until 1 year following index presentation
Reattendance with suspected myocardial infarction at 30 days	A subsequent attendance to an Emergency Department or Acute Medical Unit during which a clinician responsible for care requests measurement of cardiac troponin for suspected acute coronary syndrome.	From initial hospital discharge until 30 days following initial presentation.
Reattendance with suspected myocardial infarction at 1 year	A subsequent attendance to an Emergency Department or Acute Medical Unit during which a clinician responsible for care requests measurement of cardiac troponin for suspected acute coronary syndrome.	From initial hospital discharge until 1 year following initial presentation.
Unscheduled coronary revascularisation at 30 days	Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.	From initial hospital discharge until 30 days following initial presentation
Unscheduled coronary revascularisation at 1 year	Percutaneous coronary intervention or coronary artery bypass graft surgery undertaken on an urgent or emergency basis, excluding revascularisation undertaken during the index admission.	From initial hospital discharge until 1 year following initial presentation
Hospitalisation due to heart failure at 30 days	A hospital episode recorded in the Scottish Morbidity Record associated with ICD10 code I25.5 or I50, limited to position 1 or 2 on the discharge list.	From discharge from the initial hospital attendance until 30 days from initial presentation
Hospitalisation due to heart failure at 1 year	A hospital episode recorded in the Scottish Morbidity Record associated with ICD10 code I25.5 or I50, limited to position 1 or 2 on the discharge list.	From discharge from the initial hospital attendance until 1 year from initial presentation
Death at 30 days	Death due to any cause	From initial presentation until 30 days
Death at 1 year	Death due to any cause	From initial presentation until 1 year
Myocardial injury	Any cardiac troponin measurement above the sex-specific 99th percentile upper reference limit of the relevant assay, during the first 24 hours of the initial presentation to hospital.	From initial presentation to hospital until 24 hours after presentation.
Index myocardial infarction	Myocardial infarction during the index presentation to hospital (ICD10 codes I21 or I22 associated with the episode in the Scottish Morbidity Record, restricted to position 1 or 2	From initial presentation until hospital discharge, up to 1 year
Coronary angiography within 30 days	Invasive coronary angiography performed within 30 days of the initial presentation to hospital.	From initial presentation until 30 days later
Time until initial troponin test	Time from the arrival in the Emergency Department until collection of the first high-sensitivity cardiac troponin test.	From initial presentation to hospital until 24 hours after presentation.

Collaborators and Investigators

• Sponsor: University of Edinburgh
• Collaborators: Roche Diagnostic Ltd.
• Investigators: Principal Investigator: Andrew R Chapman, MD PhD, University of Edinburgh

Publications and helpful links

General Publications

• Boeddinghaus J, Li Z, Bularga A, Taggart C, Wereski R, Chapman AR, Lee KK, Tuck C, Gunn R, Jenks S, McCance K, Pattenden R, Malo J, Thurston AJF, Tew YY, McDermott M, Gray A, Cruden NLM, Anand A, Kimenai DM, Mills NL; TWITCH-ED Investigators. Clinical Decisions and Outcomes After Switching High-Sensitivity Cardiac Troponin Assays in Suspected ACS: An Interrupted Time-Series Study. JAMA Cardiol. 2026 Feb 1;11(2):186-192. doi: 10.1001/jamacardio.2025.4661.
• Thurston AJF, Tew YY, Lopez-Ayala P, Koechlin L, O'Brien R, Lynch S, Cooper JG, Fujisawa T, Bima P, McDermott M, Tuck C, Mizerska M, Highton-Williamson E, McCurrach F, Lowry MTH, Doudesis D, Anand A, Lee KK, Ferry AV, Chapman A, Newby DE, Boeddinghaus J, Mueller C, Gray AJ, Mills NL; POC-ET and APACE Investigators. Early Rule Out of Myocardial Infarction With a Novel High-Sensitivity Cardiac Troponin T Assay. JAMA Cardiol. 2026 Apr 22:e260477. doi: 10.1001/jamacardio.2026.0477. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2029

Study Registration Dates

• First Submitted: May 22, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 9, 2026

Study Record Updates

• Last Update Posted (Actual): June 9, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: acute coronary syndrome; myocardial infarction; cardiac troponin; accelerated decision pathway; Troponin T high sensitivity generation six
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Acute Coronary Syndrome
• Other Study ID Numbers: AC25189

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The individual data underlying the study can be made available via a Secure Data Environment to approved researchers on application to DataLoch (dataloch@ed.ac.uk)
• IPD Sharing Time Frame: From study conclusion for 5 years
• IPD Sharing Access Criteria: Access is contingent on a project application to DataLoch that fulfils key governance criteria on independent review. Further details may be obtained by contacting dataloch@ed.ac.uk
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No